A ventricular assist device (VAD) is a mechanical support attached to the native heart and vessels to augment cardiac output. The total artificial heart (TAH) replaces the native ventricles and is attached to the pulmonary artery and aorta; the native heart is typically removed. Both the VAD and TAH may be used as a bridge to heart transplantation or as destination therapy in those who are not candidates for transplantation. The VAD has also been used as a bridge to recovery in patients with reversible conditions affecting cardiac output.

Heart failure may be the consequence of a number of differing etiologies, including ischemic heart disease, cardiomyopathy, congenital heart defects, or rejection of a heart transplant. The reduction of cardiac output is considered to be severe when systemic circulation cannot meet the body’s needs under minimal exertion. Heart transplantation improves quality of life and has survival rates at 1, 5, and 10 years of 88%, 74%, and 55%, respectively. The supply of donor organs has leveled off, while candidates for transplants are increasing, compelling the development of mechanical devices.

Total Artificial Hearts

Initial research into mechanical assistance for the heart focused on the total artificial heart, a biventricular device which completely replaces the function of the diseased heart. An internal battery required frequent recharging from an external power source. Many systems use a percutaneous power line, but a transcutaneous power-transfer coil allows for a system without lines traversing the skin, possibly reducing the risk of infection. Because the native heart must be removed, failure of the device is synonymous with cardiac death.

A fully bioprosthetic total artificial heart, which is fully implanted in the pericardial sac and is electrohydrolically actuated, has been developed and tested in two patients, but is currently experimental.

Ventricular assist devices. Implantable ventricular assist devices (VADs) are attached to the native heart, which may have enough residual activity to withstand a device failure in the short term. In reversible heart failure conditions, the native heart may regain some function, and weaning and explanting of the mechanical support system after months of use has been described. Ventricular assist devices can be classified as internal or external, electrically or pneumatically powered, and pulsatile or continuous flow. Initial devices were pulsatile, mimicking the action of a beating heart. More recent devices may utilize a pump which provides continuous flow. Continuous devices may move blood in rotary or axial flow.

At least one VAD system developed is miniaturized and generates an artificial pulse, the HeartMate 3 Left Ventricular Assist System.

Surgically-implanted ventricular assist devices represent a method of providing mechanical circulatory support for patients not expected to survive until a donor heart becomes available for transplant or for whom transplantation is otherwise contraindicated or unavailable. Ventricular assist devices are most commonly used to support the left ventricle, but right ventricular and biventricular devices may be used. The device is larger than most native hearts, and therefore the size of the patient is an important consideration: the pump may be implanted in the thorax or abdomen or remain external to the body. Inflow to the device is attached to the apex of the failed ventricle, while outflow is attached to the corresponding great artery (aorta for left ventricle, pulmonary artery for right ventricle). A small portion of ventricular wall is removed for insertion of the outflow tube; extensive cardiotomy affecting the ventricular wall may preclude VAD use.

Percutaneous ventricular assist devices (pVAD).Devices in which most of the system’s components are external to the body are for short-term use (6 hours to 14 days) only, due to the increased risk of infection and need for careful, in-hospital monitoring. Some circulatory assist devices are placed percutaneously (i.e., are not implanted). These may be referred to as percutaneous ventricular assist devices (pVADs). A pVAD is placed through the femoral artery. Two different pVADs have been developed, the TandemHeart and the Impella device. In the TandemHeart system, a catheter is introduced through the femoral vein and passed into the left atrium via transseptal puncture. Oxygenated blood is then pumped from the left atrium into the arterial system via the femoral artery. The Impella device is also introduced through a femoral artery catheter. In this device, a small pump is contained within the catheter placed into the left ventricle. Blood is pumped from the left ventricle, through the device, and into the ascending aorta. Adverse events associated with pVAD include access site complications such as bleeding, aneurysms, or leg ischemia. Cardiovascular complications can also occur, such as perforation, myocardial infarction (MI), stroke, and arrhythmias.

There are several situations in which pVAD may be beneficial: 1) cardiogenic shock that is refractory to medications and intra-aortic balloon pump (IABP), 2) cardiogenic shock, as an alternative to IABP, and 3) high-risk patients undergoing invasive cardiac procedures who need circulatory support.

Intra-aortic balloon pumps are outside the scope of this policy.

A number of mechanical circulatory support devices have been approved or cleared for marketing by FDA. These devices are summarized in the table below and described further in following sections.

Available Mechanical Circulatory Support Devices

Device

Manufacturer

Date of Initial Approval

Method of FDA Clearance

Indication

Ventricular assist devices

Thoratec® IVAD

Thoratec

Aug 2004

Premarket approval (PMA) supplement

Bridge to transplant and postcardiotomy

DeBakey VAD® Child

MicroMed

Feb 2004

Humanitarian device exemption (HDE)

Bridge to transplant in children 5-16 y of age

HeartMate II®

Thoratec

Apr 2008

PMA

Bridge to transplant and destination

CentriMag®

Levitronix (now Thoratec)

Oct 2008

HDE

Postcardiotomy

Berlin Heart EXCOR® Pediatric VAD

Berlin

Dec 2011

HDE

Bridge to transplant

HeartWare® Ventricular Assist System

HeartWare

Dec 2012

PMA

Bridge to transplant

Percutaneous ventricular assist devices

Impella®

Abiomed

May 2008

510(k)

Partial circulatory support using extracorporeal bypass control unit for ≤6 h

TandemHeart®

Cardiac Assist

Sep 2005

510(k)

Temporary left ventricular bypass of ≤6 h

Total Artificial Heart

In October 2004, device CardioWest™ Temporary Total Artificial Heart (SynCardia Systems, Inc., Tucson, AZ) was approved by the U.S. Food and Drug Administration (FDA) through the premarket approval process for use as a bridge to transplant in cardiac transplant-eligible candidates at risk of imminent death from biventricular failure. Also, the temporary CardioWest™ Total Artificial Heart (TAH-t) is intended for use inside the hospital. In April 2010, the FDA approved a name change to SynCardia Temporary Total Artificial Heart.

In September 2006, the AbioCor® Implantable Replacement Heart System (Abiomed, Danvers, MA) was approved by the FDA through the Humanitarian Device Exemption (HDE) process for use in severe biventricular end stage heart disease patients who are not cardiac transplant candidates and who:

are younger than 75 years of age;

require multiple inotropic support;

are not treatable by left ventricular assist devices (LVAD) destination therapy; and

are not weanable from biventricular support if on such support.

In addition to meeting other criteria, patients who are candidates for the AbioCor® TAH must undergo a screening process to determine if their chest volume is large enough to hold the device. The device is too large for approximately 90% of women and for many men.

Ventricular Assist Devices

In December 1995, the Thoratec® Ventricular Assist Device System (Thoratec Corp., Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in patients suffering from end-stage heart failure. The patient should meet all of the following criteria:

In May 1998, supplemental approval for the above device was given for the indication for postcardiotomy patients who are unable to be weaned from cardiopulmonary bypass. In June 2001, supplemental approval was given for a portable external driver to permit excursions within a 2-hour travel radius of the hospital in the company of a trained caregiver. In November 2003, supplemental approval was given to market the device as Thoratec® Paracorporeal VAD. In August 2004, supplemental approval was given to a modified device to be marketed as the Thoratec® Implantable VAD for the same indications. In January 2008, supplemental approval was given to rescind Paracorporeal VAD use.

In February 2004, the FDA approved the DeBakey VAD® Child under the HDE process for both home and hospital use for children between the ages of 5 and 16 years who have end stage ventricular failure requiring temporary mechanical blood circulation until a heart transplant is performed.

In April 2008, continuous flow device HeartMate® II LVAS (Thoratec, Pleasanton, CA) was approved by the FDA through the premarket approval process for use as a bridge to transplantation in cardiac transplant candidates at risk of imminent death from nonreversible left ventricular failure. The Heartmate® II LVAS is intended for use both inside and outside the hospital. In January 2010, the device received the added indication as destination therapy for use in patients with New York Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure who have received optimal medical therapy for at least 45 of the last 60 days and are not candidates for cardiac transplantation.

In October 2008, device CentriMag® Right Ventricular Assist Device (Levitronix, Zurich) was approved by the FDA under the HDE process to provide temporary circulatory support for up to 14 days for patients in cardiogenic shock due to acute right-sided heart failure.

In December 2011, the Berlin Heart EXCOR® Pediatric VAD was approved by FDA via the HDE for pediatric patients with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In December 2012, FDA approved the HeartWare® Ventricular Assist System (HeartWare, Miami Lakes, FL) through the PMA. The device is approved as a bridge to cardiac transplantation in patients at risk for death from refractory end stage left ventricular heart failure.

Percutaneous Ventricular Assist Devices (Circulatory Assist Devices)

In May 2008, the Impella® Recover LP 2.5 Percutaneous Cardiac Support System (Abiomed, Aachen, Germany) was cleared for marketing by FDA through the 510(k) process for short-term (less than six hours) use in patients requiring circulatory support.

In March 2015, the Impella 2.5 System received approval through the PMA process for temporary ventricular support during high-risk percutaneous coronary interventions.

The TandemHeart® (Cardiac Assist, Pittsburgh) received a similar 510(k) approval for short-term circulatory support in September 2005.

No benefits will be provided for a covered transplant procedure or a transplant evaluation unless the Member receives prior authorizationthrough Case Management from Blue Cross & Blue Shield of Mississippi.

Postcardiotomy Setting/Bridge to Recovery

Implantable ventricular assist devices with FDA approval or clearance may be considered medically necessary in the post-cardiotomy setting in patients who are unable to be weaned off cardiopulmonary bypass.

Bridge to Transplantation

Implantable ventricular assist devices with FDA approval or clearance may be considered medically necessary as a bridge to heart transplantation for patients who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation.

Implantable ventricular assist devices with FDA approval or clearance, including humanitarian device exemptions, may be considered medically necessary as a bridge to heart transplantation in children 16 years old or younger who are currently listed as heart transplantation candidates and not expected to survive until a donor heart can be obtained, or are undergoing evaluation to determine candidacy for heart transplantation.

Total artificial hearts with FDA-approved devices may be considered medically necessary as a bridge to heart transplantation for patients with biventricular failure who have no other reasonable medical or surgical treatment options, who are ineligible for other univentricular or biventricular support devices, and are currently listed as heart transplantation candidates or are undergoing evaluation to determine candidacy for heart transplantation, and not expected to survive until a donor heart can be obtained.

Destination Therapy

Implantable ventricular assist devices with FDA approval or clearance may be considered medically necessary as destination therapy with end-stage heart failure who are ineligible for human heart transplant and who meet the following “REMATCH Study” criteria*:

New York Heart Association (NYHA) class IV heart failure for ≥60 days, OR patients in NYHA class III/IV for 28 days, received ≥ 14 days support with intra-aortic balloon pump or dependent on IV inotropic agents, with 2 failed weaning attempts

In addition, patients must not be candidates for human heart transplant for 1 or more of the following reasons:

Age >65 years; OR

Insulin dependent diabetes mellitus with end-organ damage; OR

Chronic renal failure (serum creatinine >2.5 mg/dL for ≥90 days; OR

Presence of other clinically significant condition

Other Indications

Other applications of implantable left ventricular devices or total artificial hearts are considered investigational, including, but not limited to, the use of total artificial hearts as destination therapy. The use of non-FDA approved or cleared implantable ventricular assist devices or total artificial hearts is considered investigational.

Percutaneous ventricular assist devices (pVADs) are considered investigational for all indications.

Federal Employee Program (FEP) may dictate that all FDA-approved devices, drugs or biologics may not be considered investigational and thus these devices may be assessed only on the basis of their medical necessity.

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Only two ventricular assist devices (VADs) have approval from the U.S. Food and Drug Administration (FDA) for the pediatric population. The DeBakey VAD® Child device and the Berlin Heart EXCOR Pediatric VAD have FDA approval through the humanitarian device exemption (HDE) process. The DeBakey VAD is indicated for use in children ages 5 to 16 years who are awaiting a heart transplant (i.e., a bridge to transplant) while the Berlin Heart EXCOR VAD is indicated for children with severe isolated left ventricular or biventricular dysfunction who are candidates for cardiac transplant and require circulatory support.

In general, candidates for bridge-to-transplant implantable ventricular assist devices (VADs) are those who are considered appropriate heart transplant candidates but who are unlikely to survive the waiting period until a human heart donor is available. Some studies have included the following hemodynamic selection criteria: either a left atrial pressure of 20 mm Hg or a cardiac index of <2.0 L/min/m while receiving maximal medical support. Patients with VADs are classified by the United Network for Organ Sharing (UNOS) as Status I, that is, persons who are most ill and are considered the highest priority for transplant.

The median duration for time on the device is between 20 and 120 days.

Contraindications for bridge-to-transplant VADs and TAH include conditions which would generally exclude patients for heart transplant. Such conditions are chronic irreversible hepatic, renal, or respiratory failure; systemic infection; coagulation disorders, and inadequate psychosocial support. Due to potential problems with adequate function of the ventricular assist device (VAD) or TAH, implantation is also contraindicated in patients with uncorrected valvular disease. See the Heart Transplantpolicy for further discussion of heart transplant candidacy.

In addition, patients must have sufficient space in the thorax and/or abdominal cavity for the device. In the case of the CardioWest™ Temporary Total Artificial Heart, this excludes patients with body surface areas less than 1.7 m² or who have a distance between the sternum and 10th anterior rib of less than 10 cm, as measured by CT [computed tomography] scan.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Nervous/Mental Conditions, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A. consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B. appropriate with regard to standards of good medical practice; and

C. not solely for the convenience of the Member, his or her Provider; and

D. the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of Medically Necessary, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

05/23/2014: Added "Implantable" to the policy title. Policy description updated regarding available devices. Added the following headings to the policy statement: Postcardiotomy Setting/Bridge to Recovery, Bridge to Transplantation, Destination Therapy, and Other Indications. Replaced "cleared devices" with "clearance." Added "Implantable" to the beggining of the policy statement under the Bridge to Transplantation section. Policy statement on implantable VADs as a bridge to heart tranplantation in children was revised to change the age range from "5 to 16" to "16 years old or younger," reflecting the approval of the BERLIN heart EXCOR device for pediatric patients. Policy guidelines updated to include coagulation disorders and inadequate psychosocial support as contraindications for bridge to transplant VADs and TAH. Removed deleted CPT codes 0048T and 0050T from the Code Reference section.